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Smithkline Beecham Corp. v. Copley Pharmaceutical, Inc.
Citation: 45 F. App'x 915Docket: No. 01-1611
Court: Court of Appeals for the Federal Circuit; August 15, 2002; Federal Appellate Court
SmithKline Beecham Corporation and Beecham Group P.L.C. appealed a Massachusetts District Court ruling that invalidated claims 2 and 4 of U.S. Patent No. 4,420,639 for anticipation under 35 U.S.C. § 102(b) and for unenforceability due to inequitable conduct. The appellate court affirmed the lower court's findings, noting that the determination of anticipation is a factual issue subject to review for clear error. A claim is considered anticipated if a single prior art reference discloses each limitation either explicitly or inherently, and it must enable a person skilled in the art to understand the claimed invention. The appeal involved a paper by Chatterjea and Prasad, which was determined to anticipate the claims related to nabumetone, an anti-inflammatory drug. Their publication disclosed nabumetone’s chemical structure and provided a four-step process for its synthesis, which was acknowledged by one of the patent's inventors, Dr. Carl J. Rose. Beecham's own internal documents supported this understanding, confirming that the process described by Chatterjea and Prasad successfully leads to nabumetone. Beecham contended that the article did not anticipate the patent due to a footnote referencing another source that allegedly contained a process error. However, the court found this argument unconvincing, as the error had been previously identified and corrected in an earlier publication, long before Chatterjea and Prasad's work. Thus, the court upheld the findings that the prior art sufficiently disclosed and enabled the production of nabumetone, leading to the affirmation of the patent's invalidation. Dr. Edward C. Taylor, an expert witness for Copley, indicated that a skilled practitioner would recognize the Jones error and its correction in the Ormancy reference. Beecham acknowledged in its brief that alternatives to the Jones process for producing methoxy acetate were known. Consequently, a skilled individual would interpret Chatterjea and Prasad as starting with methoxy acetate and describing nabumetone, a methoxy ketone, rather than a hydroxy ketone, based on the documents' language and intent. Additionally, in June 1982, Chatterjea informed Beecham that he had successfully repeated the four-step synthesis from his publication and confirmed the synthesis of nabumetone prior to 1973. Claim 2 specifies the chemical structure of nabumetone, differing only in that it claims the compound in solid form, while claim 4 refers to it in oil form. Expert testimony established that nabumetone is produced in an oil form but solidifies at room temperature, leading to the conclusion that the solid form is an inherent property of the compound. The court agreed with the lower court's finding that claims 2 and 4 are inherently anticipated by Chatterjea and Prasad, affirming their invalidity due to anticipation and not addressing the inequitable conduct issue.